MXPA03000283A - Bilateral extension prosthesis and method of delivery. - Google Patents

Bilateral extension prosthesis and method of delivery.

Info

Publication number
MXPA03000283A
MXPA03000283A MXPA03000283A MXPA03000283A MXPA03000283A MX PA03000283 A MXPA03000283 A MX PA03000283A MX PA03000283 A MXPA03000283 A MX PA03000283A MX PA03000283 A MXPA03000283 A MX PA03000283A MX PA03000283 A MXPA03000283 A MX PA03000283A
Authority
MX
Mexico
Prior art keywords
prosthesis
further characterized
extension
bypass
implant element
Prior art date
Application number
MXPA03000283A
Other languages
Spanish (es)
Inventor
William L Howat
Original Assignee
Johnson & Johnson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Johnson & Johnson filed Critical Johnson & Johnson
Publication of MXPA03000283A publication Critical patent/MXPA03000283A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • A61F2002/067Y-shaped blood vessels modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/077Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/825Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0013Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0034D-shaped
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Prostheses (AREA)

Abstract

The invention is a system, apparatus, and method for treating, and/or repairing an aneurysm, preferably an aortic aneurysm, and most preferably, an abdominal aortic aneurysm. The systems, devices, and methods of the present invention include a prosthesis assembly for establishing a fluid flow path between an upstream portion of an artery and at least one bifurcated downstream portion of the artery.

Description

BILATERAL EXTENSION PROTESIS AND SUPPLY METHOD CROSS REFERENCE TO RELATED REQUESTS This request is a continuation in part of the application for E.U.A. serial number 09 / 714,080, filed on November 16, 2000; application of E.U.A. number 09 / 714,078, filed on November 16, 2000; US application No. 09 / 714,079, filed on November 16, 2000 and application of E.U.A. No. 09 / 714,079, filed on November 16, 2000.
BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The present invention relates to devices and methods for correcting aneurysms, and more particularly, to percutaneously and / or intraluminally delivery devices and methods for correcting aneurysms, such as abdominal aortic aneurysms and thoracic aortic aneurysms.
Dilatation extends to the aortic bifurcation. An aneurysm of type II B comprises three dilatations. A dilation is located between the renal arteries and the iliac arteries. Like the type II A aneurysm, the aorta is healthy between the aneurysm and the renal arteries, but it is not healthy between the aneurysm and the iliac arteries. The other two dilatations are located in the iliac arteries between the aortic bifurcation and the bifurcations between the external iliac and the internal iliac. The iliac arteries are healthy between the iliac bifurcation and the aneurysms. A type II C aneurysm also comprises three dilatations. However, in a type II C aneurysm, dilatations in the iliac arteries extend to the iliac bifurcation. A type III aneurysm is a simple dilatation located between the renal arteries and the iliac arteries. In the type III aneurysm, the aorta is not healthy between the renal arteries and the aneurysm. In other words, the dilation extends to the renal arteries. An aortic aneurysm of abdominal rupture is currently the thirteenth cause of death in the United States of America. The routine management of abdominal aortic aneurysms is surgical bypass, with the placement of a graft in the involved or dilated segment. Although resection with a synthetic graft by means of a transperitoneal or retroperitoneal procedure is a standard treatment, it is associated with a significant risk. For example, complications include perioperative myocardial ischemia, renal failure, erectile impotence, bowel ischemia, infection, lower limb ischemia, spinal cord injury with paralysis, aortic-enteric fistula, and death. Surgical treatment of abdominal aortic aneurysms is associated with an overall mortality ratio of five percent in symptomatic patients, sixteen to nineteen percent in symptomatic patients, and is as high as fifty percent in patients with aortic aneurysms of abdominal rupture. The disadvantages associated with conventional surgery, in addition to the high mortality ratio, include an extended recovery period associated with the large surgical incision and the opening of the abdominal cavity, difficulties in suturing the graft to the aorta, loss of existing thrombosis to support and reinforce the graft, the inconvenience of surgery for many patients who have abdominal aortic aneurysms, and the problems associated with performing surgery on an emergency basis after the aneurysm has ruptured. In addition, the typical recovery period is one to two weeks in the hospital and a period of convalescence at home from two to three months or more, if complications arise. Since many patients who have abdominal aortic aneurysms have other chronic diseases, such as heart, lung, liver and / or kidney diseases, coupled with the fact that many of these patients are older adults, these are less than ideal candidates for surgery.
The presence of aneurysms is not confined to the abdominal region. Although abdominal aortic aneurysms are usually the most common, aneurysms in other regions of the aorta or one of its branches are possible. For example, aneurysms in the thoracic aorta may occur. As is the case with abdominal aortic aneurysms, the widely accepted approach to treating an aneurysm in the thoracic aorta is surgical correction, which involves the replacement of the aneurysmal segment with a prosthetic device. This surgery, as described above, is a larger company, with high risks and with significant mortality and morbidity. During the past five years, there have been a large number of developments aimed at implementing less invasive, endovascular techniques, that is, directed with a catheter, for the treatment of aneurysms, specifically abdominal aortic aneurysms. This has been facilitated by the development of vascular stent elements, which can and have been used in conjunction with standard or thin-walled graft material in order to create an implant-graft element or endografts. The potential advantages of less invasive treatments include reduced surgical morbidity and mortality along with shorter stays in the hospital and in the intensive care unit. The elements of implant-grafts or stents are now approved by the FDA and are commercially available. These delivery procedures typically involve advanced angiographic techniques performed through vascular accesses gained through surgical cutting of a remote artery, which may include the common femoral or branchial arteries. The introducer of appropriate size should be placed on a guide wire. The catheter and guide wire are passed to the aneurysm. Through the introducer, the implant-graft element must advance to the appropriate position. The typical deployment of the implant-graft device requires the removal of an outer mantle while maintaining the position of the implant-graft element with an internal stabilizing device. The majority of implant-graft elements are self-expanding; however, an additional angioplasty procedure, e.g., balloon angioplasty, may require securing the position of the implant-graft element. After placement of the implant-graft element, standard angiographic views can be obtained. Due to the large diameter of the devices described above, typically greater than twenty French (3F = 1 mm), the closed arteriotomy typically requires the opening of surgical corrections. Some procedures may require additional surgical techniques, such as hypogastric artery embolization, vessel ligation, or surgical bypass, in order to adequately treat the aneurysm or to maintain flow in both lower extremities. Similarly, some procedures will require additional techniques, directed to the advancing catheter, such as angioplasty, implant element placement, and embolization, in order to successfully exclude the aneurysm and efficiently manage the openings. Although the stents described above represent a significant improvement over conventional surgical techniques, stents need to be improved, their method of use and their applicability for varied biological conditions. Accordingly, in order to provide alternative safe and effective means for treating aneurysms, including abdominal aortic aneurysms and thoracic aortic aneurysms, a number of difficulties associated with currently known stents and their delivery systems must be overcome. A pre-coupling with the use of endoprostheses is the prevention of endoleaks and the rupture of the normal dynamic fluids of the vascularity. Devices that use any technology should preferably be simple to place and reposition as necessary, preferably they should provide a sharp, narrow seal of the fluid, they should preferably be anchored to prevent migration without interfering with normal blood flow in both the aneurysmal vessels as well as in the branched vessels. In addition, devices using the technology should preferably be capable of anchoring, sealing, and holding in bifurcated vessels, tortuous vessels, highly angulated vessels, partially diseased vessels, calcified vessels, loose vessels, short vessels, and long vessels. In order to accomplish this, the stents should preferably be extended and reconfigured while maintaining narrow long-term fluid seals and treble and anchored positions. The stents should preferably also be capable of being delivered percutaneously using catheters, guidewires and other devices that substantially eliminate the need for open surgical intervention. Consequently, the diameter of the stent in the catheter is an important factor. This is especially true for aneurysms in larger vessels, such as the thoracic aorta.
BRIEF DESCRIPTION OF THE INVENTION The bilateral extension prostheses of the present invention provide a means to overcome the problems associated with anchoring and / or sealing of bypass prostheses in bifurcated sections of arteries as briefly described above. The present invention is directed to a system that includes at least one prosthesis to correct or replace a part of the body or condition of a mammal. The typical system includes a first prosthesis to seal the system within a certain portion of an artery; At least one second prosthesis occupying the first prosthesis, the second prosthesis provides a fluid flow path through the system or a portion of the system; and a third or extension prosthesis to extend the fluid flow path through the system or a portion of the system. In some embodiments of the invention, the second prosthesis is stamped and / or paired with the first prosthesis. In some embodiments of the invention, the extension prosthesis extends the fluid flow path formed by the second prosthesis. In some embodiments of the invention, the extension prosthesis is occupied sealingly and / or matched with the second prosthesis. The present invention further comprises a first extension prosthesis configured to occupy a proximal portion of the first bypass prosthesis, the first extension prosthesis configured with a distal portion placed in a small arterial vessel, such as the external iliac artery. The present invention may further comprise a second extension prosthesis configured to occupy a proximal portion of the first bypass prosthesis, the second extension prosthesis configured with a distal portion placed in a small arterial vessel, such as an internal iliac artery. A typical first prosthesis includes a support or implant element structure, and a foam or joint material supported by the implant element, the implant member and the joint material are configured to seal the system within an artery. A typical first prosthesis also includes one or more structures or elements to occupy the second prosthesis. In preferred embodiments of the invention, these elements or structures are sealed and / or matched to the second prosthesis. The implant element is typically a natural or synthetic matrix for supporting the joint material. In some exemplary embodiments of the implant member, the implant member is an orifice, substantially cylindrical, and preferably a radially expandable matrix having a lumen and two open ends. The typical gasket material is a synthetic or natural fabric, fabric, foam, or the like. In preferred embodiments of the invention, the gasket material covers at least a portion of lumen, or even more preferably, the proximal end of the lumen. The second typical prosthesis includes a support or structure of an implant element, and a graft material supported by the implant member, the implant member and the graft material define a fluid flow path therebetween. The typical graft material is a synthetic or natural fabric, fabric, or the like. The implant element is typically a synthetic or natural matrix for supporting the graft and / or placing the prosthesis in a predetermined position. In some exemplary embodiments of the implant member, the implant member is an orifice, substantially cylindrical, and preferably a radially expandable matrix, having a lumen and two open ends. The implant element typically comprises a plurality of interconnected struts. In some exemplary embodiments of the invention, the graft material may be placed on an internal and / or external surface of the matrix; In preferred embodiments of the invention, the graft material may include a plurality of substantially longitudinally directed folds disposed therebetween.
In a particularly preferred embodiment, the graft further includes a plurality of radially oriented pleat interruptions. In some exemplary embodiments of the invention, the graft material may be attached to the implant element preferably by one or more staples or the like. A prosthesis in accordance with the invention, typically a bypass prosthesis, may include, or may be configured to include, at least one joint member positioned or that may be placed in a distal portion of the bypass prosthesis. In this exemplary embodiment of the invention, the gasket member may be adapted to receive one or more extension prostheses in a narrow fluid placement. Additionally, a bypass prosthesis can be modified to provide bifurcated access to one or more downstream arteries. For example, a bypass prosthesis can be configured or include elements that allow the delivery of one or more extension prostheses through or linked by the bypass prosthesis and in a downstream artery. Such an assembly allows the placement of at least one prosthesis through the bifurcated portion of an arterial channel. Coupling or entanglement elements may be incorporated into the design of the shunt prosthesis, or a distal portion of the shunt prosthesis may be delivered in vivo. Such coupling elements form an interlaced communication at the desired positions in the bypass prosthesis, preferably during the in vivo assembly of the system according to the invention.
The system according to the present invention is intended to correct or deviate an aneurysm, preferably an aortic aneurysm. The system can also be used to direct the flow of fluid from one portion of one fluid path to another. The accompanying figures show illustrative embodiments of the invention of which these and other objectives, novel features and advantages, will be readily apparent.
BRIEF DESCRIPTION OF THE DRAWINGS The above and other aspects of the present invention will be better appreciated with reference to the detailed description of the invention in conjunction with the accompanying drawings. Through the figures and the description below, such numbering indicates the same element. Figure 1 is an elevation view of the fully deployed aortic correction system made in accordance with the present invention. Figure 2 is a perspective view of an implant element for a first prosthesis, shown for clarity in an expanded state. Figure 3 is a perspective view of a first prosthesis having an implant element covered with a graft material.
Figure 4 is a lateral elevation of a second prosthesis having an implant element covered by a graft material. Figure 5 is a side elevation of an implant element for a second prosthesis, shown for clarity in an expanded state. Figure 6 is a lateral elevation of the longitudinally positioned graft material, configured to be placed in the implant element of Figure 5. Figure 7 is a perspective view of a first fully deployed prosthesis made in accordance with the present invention and a Exemplary supply system. Figure 8 is a terminal view of the graft material, taken along the line 8-8 view shown in Figure 6, illustrating the graft material in an unexpanded or hooked configuration, and in its fully expanded configuration . Figures 9 through 11 show an exemplary connector assembly of the present invention, intended for use in an end portion of the implant element or prosthesis. Figures 12 through 14 show an assembly of the alternative connector of the present invention, intended for use in an intermediate portion of the implant element or prosthesis. Figure 15 is a schematic, partial perspective view of the proximal end of a second prosthesis of the present invention, illustrating an anchoring and delivery system in accordance with the invention.
Figure 16 is a perspective view of a system according to the invention, having a bypass prosthesis and a first extension prosthesis extending into a first iliac artery. Figure 16a is a cross-sectional view of the first and second extension prostheses taken along section line 16a-16a, shown in Figure 16. Figures 17a and 17b illustrate an alternative connector assembly of the present invention, wherein the connector is a suture or the like having a spherical or knotted end. Figure 18 is a final view of an extension receptacle configured as a cover for the distal end of the bypass prosthesis. Figure 19 is a final view of an extension receptacle configured as an occlusion member configured to occupy an internal and distal portion of the bypass prosthesis. Figure 20 is a cross section of a first prosthesis taken along section line 20-20 shown in Figure 3 in accordance with the present invention. Figures 21 (a-c) are top views of alternative embodiments of a cover in a first prosthesis in accordance with the present invention.
DETAILED DESCRIPTION OF THE PREFERRED MODALITIES The apparatuses, systems, methods, and kits of the present invention can be used in the treatment of aortic aneurysms, preferably an abdominal aortic aneurysm, among other uses noted below. A better understanding of the present device and its use in the treatment of aortic aneurysms will be carried out by reading the following description in conjunction with the references incorporated above. The present invention is directed to a system, apparatus, method and their respective components for stabilizing a fluid pathway of a portion of an artery, in a bifurcated or branched portion of a portion downstream of the arterial channel. The system of the present invention includes at least one bypass prosthesis and at least one extension prosthesis, the bypass prosthesis comprises an extension or anchor socket in the distal portion thereof, the extension prosthesis has a proximal portion of the same adapted and configured to occupy the extension receptacle. In exemplary embodiments of the invention that include more than one extension prosthesis, the system further comprises an extension receptacle having a first portion adapted to receive a first extension prosthesis and a second portion adapted to receive a second extension prosthesis.; the system further comprises a first extension prosthesis having a proximal portion adapted and configured to occupy the first portion of the extension receptacle, and a second extension prosthesis having a proximal portion adapted and configured to occupy the second portion of the extension receptacle. . A system in accordance with the present invention may also include one or more gasket members configured to seal the path or communication channel between the extension receptacle and the extension prosthesis. The joint member can be configured differently. In some exemplary embodiments of the invention, the gasket member may be a portion of the extension receptacle surrounding the opening. In some exemplary embodiments of the invention, the seal member may comprise an outer ring around a proximal portion of the extension prosthesis, the outer annulus being configured to seally occupy the extension receptacle opening. In other exemplary embodiments of the invention, the seal member may comprise a separate ring configured to be positioned around the proximal portion of the extension prosthesis. The invention also contemplates the use of various combinations of these different joint modes. The present invention also comprises a system, apparatus, and method for bifurcating a single fluid flow path in two fluid flow pathways. The extension receptacle noted above for bifurcating the simple fluid flow path comprises a generally annular member or the like, which conforms to, and establishes a, tight fluid connection through a cross-section of the bypass prosthesis. The annular member may include one or more adapted openings configured to receive a proximal portion of an extension prosthesis. The present invention is also directed to a system for correcting an aneurysm, the system being configured differently and / or assembled using components described in more detail below. Typical systems in accordance with this aspect of the invention may include one or more first prostheses or a sealing component, one or more second prostheses or a fluid flow component, and, optionally, one or more receptacles of components, assemblers, or connectors to keep one component coupled with the other. Preferred embodiments of the system of the present invention include a sealed component that holds the two components of the fluid flow path together. The method according to the present invention comprises providing a bypass prosthesis, and sealingly maintaining at least one extension prosthesis in a distal portion of the bypass prosthesis. In preferred embodiments of the invention, a distal portion of the extension prosthesis may be placed in a downstream artery, preferably an iliac artery. The method according to the present invention can include sequentially sealingly coupling a first extension prosthesis and a second extension prosthesis in a distal portion of the bypass prosthesis, and positioning the first extension prosthesis in a first downstream artery, such as a first or internal iliac artery, and placing the second extension prosthesis in a second downstream artery, such as a second or external iliac artery. The present invention also includes a delivery method for placing a prosthesis in the internal iliac artery by means of a femoral, gill-cephalic or radial insertion route. In these exemplary embodiments of the invention, a guide wire is passed through the bypass prosthesis proximal to the distal artery, and into the internal iliac artery. A similar delivery catheter comprising an extension prosthesis can then be passed over the guide wire, again proximally distally and into the internal iliac artery. The extension prosthesis can then be deployed, with the proximal towed end of the prosthesis keeping a distal portion of the bypass prosthesis occupied, as described above. The delivery method may further comprise supplying a second extension prosthesis through a guidewire / catheter assembly that passes from the external iliac artery into the distal portion of the bypass prosthesis. In this exemplary embodiment of the invention, the proximal or main end of the prosthesis is held coupled by the distal portion of the bypass prosthesis, as described above. In preferred embodiments of the invention, the method includes anchoring the system using the second prosthesis in its expanded configuration. The method may further include anchoring the majority of the upstream portion of the system using the first portion of the implant element, matrix or first prosthesis. The present invention is also directed to a case that includes one or more of the following: a sterile or sterilizable lock; a first prosthesis; a first prosthesis in a single sterile lock; a second prosthesis; a second prosthesis in a single sterile lock; a third prosthesis; a third prosthesis in a single sterile lock; a bypass prosthesis; a bypass prosthesis in a single sterile lock; at least one extension prosthesis; at least one extension prosthesis in a single sterile lock; a board member; a sealing member in a single sterile lock; at least one suture; at least one staple; a collar or assembled catheter tip configured to occupy and deliver a first prosthesis, a second prosthesis and / or a third prosthesis; and at least one marker configured to be placed on the first prosthesis, the second prosthesis, the third prosthesis and / or portions thereof. The present invention also includes a case comprising a prosthesis according to the invention, preferably in a sterilizable or sterile lock. A system or case of the present invention may include one or more modular components. As used herein, a modular component is configured, or adapted to occupy, or includes one or more structures that are intended to communicate with, or occupy, a complementary structure with another modular component.
The embodiments of the invention may include one or more bypass prostheses configured to keep a first prosthesis occupied, the bypass prosthesis comprises a graft material occupying an implant element, the implant member comprises an orifice matrix including a series of interconnected struts, the array can be moved from a first closed portion to a second open position; the implant element has at least one link structure or connector to keep at least a second complementary structure occupied in the first prosthesis. In some exemplary embodiments of the invention, the prosthesis further comprises at least one marker. In preferred embodiments of the invention, the marker or markers are placed on, or are part of, the implant element. The systems, methods and prostheses of the present invention can be used to treat or correct Schumacher's disease of the IIC AAA type, preferably without the need for surgery and / or without compromising peripheral flow.
Definitions As used herein, aortic aneurysm refers to any failure of a conduit, such as an aortic wall, typically characterized by a desirable dilation of a portion of the artery, malformation of the vessel, or an occlusion. An exemplary use of the system and method of the present invention is to correct an aortic aneurysm, the use of such term is not intended to be limited to the use of the structures or systems of the present invention to correct or replace other duct failures. The system and structures of the present invention can be used to treat, correct, replace, or derive any blood vessel (e.g., artery, vein, capillary); any vessel that carries fluid (for example, lymphatic vessels); any organ or portion thereof that includes a blood or fluid vessel; or any joint between the blood vessels, between the vessels of fluid, and between the organs and blood vessels. In preferred embodiments of the invention, the system and structures are used to treat, correct, replace, or derive an abdominal aortic aneurysm. As used herein, the fluid path refers to any in vivo structure through which a biological fluid passes. A preferred fluid pathway is an artery. Fluid pathways include, but are not limited to, channels formed by an artery, a vein, a capillary, lymph nodes and channels, and arteries, veins and capillaries, within an organ or organelle. As used herein, the biological fluid or fluid refers to any fluid produced by an animal, including a human. Exemplary biological fluids include, but are not limited to, blood, oxygenated blood, deoxygenated blood, gastric fluid, amniotic fluid, spinal and lymphatic fluid. The preferred fluid is blood or oxygenated blood. As used herein, the conduit typically refers to any structure used to carry a biological fluid. The conduit can be formed of natural or synthetic materials, or combinations thereof. Exemplary conduits include, but are not limited to, an artery, a vein, a capillary, lymph nodes and channels, and arteries, veins and capillaries within an organ or organelle. As used herein, "biofusion" is a word created by reference assigned to the ability of cells, proteins, fibrin, and other biological molecules to be incorporated into the pore structure of a material, such as a foam or material joint, or a graft material. This characteristic is considered to promote a long-lasting stable biological inferium that does not separate about six weeks after implantation. The effect of biofusion has many advantages. It has the potential to bypass the latest endo-effusion to prevent areas of the unorganized clot from shifting or recanalizing. It is also considered that biofusion creates a collar of connective tissue around the prosthesis that can prevent the aortic neck from dilate over time. The restriction of the dilation of the neck prevents the effusion of the two routes and the migration of the implant that can be caused by an insufficient placement with the aorta. As used in this, adapted for communication, communicating, or similar terms refer to any means, structure or methods to establish an operational association between two elements of the system. Similarly, coupled, adapted for coupling, or similar terms refer to means, structures, or methods for contacting a first component, structure or portion thereof with a second component, structure or portion thereof. Exemplary structures are shown in the figures. Typically, all of these terms and phrases refer to at least one structure in or on a first component configured to occupy a complementary structure in or on a second component, and the use of these inter-coupling features to link a first prosthesis or component. with a second prosthesis or component. The coupling or communication can be maintained (for example, permanent) and / or releasable (for example, temporarily). In preferred embodiments of the invention, the communication or coupling may be narrow fluid, substantially narrow fluid, or narrow fluid to extend until it does not sequentially compromise the intended function of the structure. For example, one connector may be adapted to receive or connect to a complementary connector in another prosthesis. As used herein, the connector refers to any structure to form a bond or a link itself to another component or portion thereof. These connectors or connections establish a flow path through various elements of the apparatus, assembly or systems. In a preferred embodiment of the invention, the system is intended to establish at least one fluid flow path through a vessel, conduit, organ, or portions thereof. Typical connections include, but are not limited to, assembly connections, such as the Luer type, screw type, friction type, or connectors that are bonded together.
As used herein, distal is used in accordance with its ordinary definition of the dictionary, for example, with reference to the furthest portion of the beginning; In human anatomy, this term is commonly equivalent to caudal or inferior. Next it is used in accordance with its ordinary definition of the dictionary, for example, with reference to the nearest position of the beginning; In human anatomy, this term is commonly equivalent to cranial or superior. The terms distal and proximal are intended to imply opposite ends or portions of a device, channel, element, or structure. In relation to the fluid flow path, distal typically refers to the downstream location in the fluid flow path, and next typically refers to the upstream location, unless otherwise specified. Anatomically, distal is usually referred to as "moving away from the heart" and next usually refers to "approaching the heart". A system for treating an aortic aneurysm according to the invention typically includes a first prosthesis or precursor implant element and at least one second prosthesis. In preferred embodiments of the invention, system components are delivered intraluminally to the site of the aneurysm using a catheter or the like. Someone skilled in the art, therefore, will recognize that it is beneficial to supply the system components in a close or first position, and to deploy the component in its functional location by expanding the component in an open or second position.
Each of the components of the system will now be described in more detail. Any reference to the Figures will be used to illustrate one or more exemplary embodiments of the invention, without intending to limit the invention thereby.
System A system in accordance with the present invention can include one or more prostheses. In the exemplary system shown in Figure 1, the system includes a first prosthesis 10 and two second prostheses 11a and 11b, which, in combination, deflect an aneurysm 100. In preferred embodiments of the invention, a proximal portion of the system can be placed in a portion 101 of an artery upstream of the aneurysm 100, and a distal portion of the system may be placed in a downstream portion 102 of the artery or a different artery. The prosthesis of the present invention includes a bracket, implant element, or grid of interconnected struts defining an interior space having a proximal end opening and a distal end opening. The grid also defines an interior surface and an exterior surface. The inner and / or outer surfaces of the grid, or a portion of the grid, can be covered by, or support, at least one covering material, such as a foam or graft material. As noted in more detail below in relation to the components of specific systems, some prostheses of the present invention can be configured to seal and / or anchor the system in place, and / or to receive and place other prostheses. Typically, these prostheses do not by themselves define a fluid flow path. Other prostheses can be configured to define at least one fluid flow path. Typically, these prostheses define a channel or the like through which fluid, such as blood, flows. This channel or fluid flow path is typically upstream of, or in an upstream portion of, a system component. In some embodiments of the invention, the fluid flow path deflects the aneurysm. In preferred embodiments of the invention, a prosthesis can be moved between an expanded or inflated position and an unexpanded or deflated position, and any position therebetween. An exemplary embodiment of this feature of the invention is shown in Figure 8, and is intended to generally illustrate an implant element graft or implant element in its expanded or unexpanded position. In some exemplary embodiments of the invention, it may be desired to provide a prosthesis that moves only from completely collapsed to fully expanded as indicated by the arrows in Figure 8. In other exemplary embodiments of the invention, it may be desired to expand the prosthesis, then collapse or partially collapse the prosthesis. Such ability is beneficial in suggesting proper placement or repositioning in the prosthesis. In accordance with the invention, the prosthesis can be self-expanding, or it can be expanded using an inflation device such as a balloon or the like.
One embodiment of a system for treating an abdominal aortic aneurysm in accordance with the present invention is shown in Figure 1. For purposes of this modality, the system is deployed in the infrarenal neck 101 of the abdominal aorta, upstream of where the anterior grooves in the common iliac arteries right T left. Figure 1 shows a first prosthesis or implant element seal 10 placed in the infrarenal neck 101; two second prostheses 1 1 a and 1 1 b, the proximal ends of which hold a proximal portion of the implant element seal 10, and the distal ends of which extend into the common iliac artery 1 or 2. illustrated, the body of the prosthesis forms a conduit or fluid flow path that passes through the location of the aneurysm 100. In preferred embodiments of the invention, the system components define a fluid flow path that bypasses the the artery where the aneurysm is located. Above the first prosthesis are the renal arteries 3, 4. These and other characteristics of the prosthetic devices and systems of the present invention will now be described in more detail.
First prosthesis or sealing prosthesis The first prosthesis includes a support matrix or implant element that supports a sealing material or foam, at least a portion of which is located through the biological fluid flow path, for example, through a blood flow pathway. In preferred embodiments of the invention, the first prosthesis, the implant member, and the sealing material are radially expandable, and define an orifice space between the proximal portion of the prosthesis and the distal portion of the prosthesis. The first prosthesis may also include one or more structures to place and anchor the prosthesis in the artery, and one or more structures to occupy and fix at least one second prosthesis in place, for example, a bypass prosthesis. The support matrix or implant element of the first prosthesis may be formed from a wide variety of materials, may be configured in a wide variety of forms, and its forms and uses are well known in the art. Exemplary implant elements of the prior art are described in the U.S. Patents. 4,733,665 (Palmaz); Patent E.U.A 4,739,762 (Palmaz); and Patent E.U.A. 4,776,337 (Plamaz), each of the above patents is incorporated herein by reference. In preferred embodiments of the invention, the implant element of the first prosthesis is a collapsible, flexible, self-expanding die or grid formed of a metal or metal alloy, such as nitinol or stainless steel. The structures formed of stainless steel can be made self-expandable by configuring the stainless steel in a predetermined manner, for example, in rotation in a tensioned configuration. More preferably, the implant element is a tubular structure that supports a sealing material. The term tubular, as used herein, refers to any shape having a side wall or side walls that define an orifice space or lumen extended therebetween; the transverse shape may be generally cylindrical, elliptical, oval, rngular, triangular or of any other shape. Additionally, the shape can change or deform as a result of various forces that can press against the implant element or the prosthesis. The sealing material or joint member supported with the implant element can be formed with a wide variety of materials, can be configured in a wide variety of ways, and its forms and uses are well known in the art. Exemplary materials for use with this aspof the invention are described in US Patent E.U.A. 4,739,762 (Palmaz) and Patent E.U.A. 4,776,337 (Palmaz), both incorporated herein by reference. The sealing material or seal member may comprise any suitable material. Exemplary materials are composed of a biocompatible and biocompatible material, including, but not limited to, open cell foam materials and closed cell foam materials. Exemplary materials include polyurethane, polyethylene, polytetrafluoroethylene; and other different polymer materials, preferably entangled or woven, which provides a flexible structure such as Dacron®. Highly compressible foams are particularly preferred, preferably to maintain the low engagement profile for better delivery. The sealing material or foam is preferably substantially impenetrable to the blood when it is in a compressed state. The sealing material can cover one or more surfaces of the implant element, that is, it can be located along an inner or outer wall, or both, and preferably extends through the proximal end or a proximal portion of the implant element . The sealing material helps prevent any blood from flowing around the first prosthesis, for example, between the first prosthesis and the arterial wall, and around one or more bypass prostheses after they have been deployed within the lumen of the prosthesis. the first prosthesis (described in more detail below). In preferred embodiments of the invention, the sealing material tapers or covers a portion of the proximal end of the implant member and along at least the portion of the outer wall of the implant member. In some embodiments of the invention, it may be desired for the portion of the sealing material to cover the proximal portion of the implant member to include one or more holes, openings, dots, slots, sleeves, skirts, attenuated spots, guides, or the like for placing a guide wire, to place a system component, such as a second prosthesis, and / or to occupy, preferably hold coupled, one or more system components, such as a second prosthesis. For example, the sealing material configured as a cover or the like, and having a hole, can partially occlude the lumen of the implant element. These openings can be configured in a varied manner, primarily to conform to their use. These structures promote proper side-by-side placement by the lateral placement of one or more, preferably multiple, prostheses within the first prosthesis, and, in some embodiments of the invention, the sealing material can be configured or adapted to assist in maintenance of a certain form of the system or component fully deployed. In addition, these openings may exist prior to the deployment of the prosthesis, or may be formed in the prosthesis as part of the unfolding procedure. The different functions of the openings will be apparent from the following description. In preferred embodiments of the invention, the sealing material is a foam having a single hole. The sealing material can be linked to the implant element by any of a variety of connectors, including a plurality of conventional sutures of polyvinylidene fluoride, polypropylene, Dacron®, or any other suitable material and bond thereto. Other methods of bonding the sealing material to the implant member include adhesives, ultrasonic welding, mechanical interference placement and staples. One or more markers may optionally be arranged in or on the implant element between the proximal end and the distal end. Preferably, two or more markers are aligned and / or positioned to identify a location on the prosthesis, or to identify the location of the prosthesis, or a portion thereof, in relation to an anatomical feature or other component of the system. The first prosthesis is typically deployed in an arterial passage upstream of the aneurysm and functions to open and / or expand the artery, to properly position and anchor the different components of the system, and in combination with other components, seal the system or portions thereof. of fluid spills. For example, the sealed prosthesis can be deployed within the infrarenal neck, between an abdominal aortic aneurysm and the patient's renal arteries to assist in the correction of abdominal aortic aneurysm. Figures 1-3 show a first exemplary prosthesis 10 of the present invention. The first prosthesis 10 includes a grid, support or self-expanding cylindrical or oval implant element 12, typically made of a plurality of interconnected struts 13. The implant element 12 defines the interior space or lumen 18 having two open ends, a proximal end 14 and a distal end 16. One or more markers 15 may optionally be disposed in or on the implant element between the proximal end 14 and the distal end 16. The implant element 12 may further include at least two, but preferably eight (as shown in Figure 2). ) spaced apart longitudinal extremities 20. Preferably, it is an extended limb from each vortex 1 1 of the interconnected struts in diamond shape 13. At least one end 20, but preferably each end 20, includes an adjacent flange 28 at its distal end that , as described in more detail below, allows the implant element to be recovered in its delivery apparatus after to unfold partially or almost completely so that it can return, or otherwise be repositioned for proper alignment. Figure 3 shows the sealing material 30 covering the proximal end of the implant element seal 10. In the embodiment shown in Figure 3, the sealing prosthesis 10 includes a seal or sealing material 30 having a first opening. or hole 32 and a second opening or slot 33. The seal material 30 covers at least one interior or exterior portion of the implant member, and more preferably substantially covers all of the exterior of the implant member. For example, the gasket material 30 can be configured to cover the implant element 12 from the proximal end 14 to the distal end 16, but preferably does not cover the longitudinal ends 20. The sealing material helps to prevent any blood from spilling around. of the bypass prosthesis 11 a and 11 b after it has been deployed (as shown in Figure 1), and from the flow around the implant element seal 10 by itself. For this exemplary embodiment, the sealing material 30 is a compressible member or seal located around the exterior of the implant element 12 and at least a portion of the interior of the implant element 12.
Preferred embodiments of the invention are illustrated in Figures 20 and 21 (a-c). These figures show a first prosthesis 10 having a gasket material 30 covering at least a portion of the proximal end of the first prosthesis 10. The gasket material 30 preferably includes a division extending approximately around the diameter of the cross section of the gasket. the first prosthesis 10, wherein the division includes a thick joint material or further includes a foam or the like. The division may be formed from any of the gasket or foam materials described above. The exemplary embodiments illustrated in Figures 20 and 21 (a-c) include a coarse division 71 in a roughly hourglass shape, although other shapes and sizes may be used. The division defines at least one section 72 within the prosthesis that has less or similar material, these sections are configured to receive a proximal end of a second prosthesis, as described in more detail below. In the exemplary embodiments shown in Figures 21 (a-c), the division 71 defines a first section 72a and a second section 72b; the first section 72a is configured to receive a first second prosthesis 1a, and the second section 72b is configured to receive a second second prosthesis 11b, as described below. According to the present invention, it may be desired to include one or more fibers, yarns, sutures, filaments, strips, or the like to further define the section 72. In the following description, the word fiber is used as a short description for the element that includes fibers, threads, filaments, threads or the like. In preferred embodiments of the invention, the fibers, etc., assist to place a second prosthesis 11a, b. In accordance with the present invention, the fiber or yarn can be formed of any material and / or comprises any construction suitable for use in the biological environment, for example, suitable for use in a blood vessel. The fiber may be woven or non-woven, formed of a synthetic or natural material, and / or of single or multiple filaments. Exemplary materials for forming the fiber or yarns include, but are not limited to, polyester, Teflon®, polyurethane, silicone, polyethylene terephthalate, and expanded polytetrafluoroethylene (ePTFE). The fiber or thread can also take other forms. For example, the fiber or yarn may be formed of glues or adhesives, or by fused sections of the joint material. In addition, the fiber or yarn may comprise struts that deform the circumferential plane. The end or ends of the fiber may be unbonded or linked. In a preferred embodiment of the invention, both ends of the fiber are bonded or fixed. For example, the ends may be sewn or fixed for coverage 31. In a preferred embodiment of the invention, the ends of the fiber are fixed to the strut 13, still more preferably to the proximal portion of the implant element 12. One or more portions of the fiber can be attached to the implant element 12 or the strut 13 by spinning, knotting, sewing, with adhesives, or any other mechanism for fixing the portion of the fiber in place.
In exemplary embodiments of the invention illustrated in Figures 21 (a-c), the fiber can be configured in various ways. In Figure 21a, the fibers 73a and 73b may be interwoven in the cover 31, and define or form a first section 72a and a second section 72b, as noted above. As shown, the ends of the fibers can be fixed to a strut; see 74a, 74b, 74c, and 74d. In Figure 21 b, a single fiber 73c can be placed around the diameter of the cover 31, and attached to a strut at 74e and 74f. In Figure 21c, one or more cross fibers 73d and 73e can be used to form or define sections 72a and 72b respectively. In the illustrated embodiments, the ends can be linked to the implant elements 12 to 74a, 74b, 74c and 74d. In some embodiments in accordance with the present invention, it may be desired to use a fiber that is brittle or can be broken. In these exemplary embodiments of the invention, the fiber is broken when the unexpanded prosthesis expands to its fully deployed position. Alternatively, the ends of the fibers can be fixed so as to be released to the implant element or strut when the prosthesis is in a collapsed condition, with one or more ends being released when the prosthesis is expanded to its fully deployed position. These structures promote proper side-by-side placement by placing one or more, preferably a diversity, of prostheses within the first prosthesis 10.
Second prosthesis The second prosthesis is a bypass conduit or the like, which typically deploys in the arterial line upstream of an aneurysm, and establishes a fluid flow path through the system or a portion thereof. In some embodiments of the invention, the second prosthesis defines a fluid flow path that passes through the arterial segment having the aneurysm, for example, by diverting the aneurysm. In these exemplary embodiments of the invention, the second prosthesis extends from a healthy portion of the artery, notwithstanding that the arterial segment has the aneurysm, and in the other healthy portion of the artery or other artery. The second prosthesis functions to derive the portion of the conduit that contains the aneurysm, and to properly position and / or anchor the proximal end of the system in the artery. In some embodiments of the invention, the second prosthesis defines a fluid flow path from one portion of the system, eg, a proximal or end portion, to another portion, eg, a distal portion or end, or an intermediate portion. The second prosthesis may also include one or more structures for positioning and anchoring the second prosthesis in the artery or in the first prosthesis. In a preferred embodiment of the invention, the second prosthesis is adapted to occupy the first prosthesis. One or more markers may optionally be arranged in or on the implant element between the proximal end and the distal end. Preferably, two or more markers are aligned and / or positioned to identify a location on the prosthesis, or to identify the location of the prosthesis, or a portion thereof, in relation to an anatomical feature or other component of the system. In preferred embodiments of the invention, fluoroscopically identifiable sutures or staples are used; These sutures or staples can attach the graft material to the implant element. Figures 1 and 4-6 show a second exemplary prosthesis or branch 1 1a, b of the present invention. The second prosthesis 1 1a, b includes a grid, support, or substantially cylindrical self-expanding implant element 40, typically made of a plurality of interconnected struts 44. The grid 40 defines an interior space having two open ends, a proximal end 41 and a distal end 42. The inner and / or outer surfaces of the grid 40 may be covered by, or support, at least one graft material 60. The second prosthesis typically includes a support matrix or implant element that supports a graft material. . One end of the second prosthesis is typically adapted to occupy one or more portions of the first prosthesis. In preferred embodiments of the invention, the proximal end of the second prosthesis is adapted to keep a proximal portion of the first prosthesis occupied. The second prosthesis may optionally include at least one linker structure at its distal end to occupy and secure the prosthesis in a portion of an artery downstream of the aneurysm. These and other features of the second prosthesis will be described in more detail below.
Extension Prosthesis An extension prosthesis in accordance with the present invention is a conduit or the like that typically deploys in an arterial line, and extends from a second bypass prosthesis into another portion of the artery, another artery, or a portion of an artery. a bifurcated arterial channel. The system comprises the extension prosthesis functioning to derive the portion of the conduit containing the aneurysm, and to appropriately position and / or anchor the proximal end of the system in an artery. The extension prosthesis may also include one or more structures for positioning and anchoring the extension prosthesis in the artery or in the second prosthesis. In a preferred embodiment of the invention, the extension prosthesis is adapted to occupy a distal portion of the second prosthesis. Figure 16 shows an exemplary extension prosthesis 160 of the present invention. In exemplary embodiments of the invention, the extension prosthesis 160 can be configured as described above for the second prosthesis 1 1a or 11 b (Figures 4-6). The extension prosthesis 160 includes a grid, support, or substantially cylindrical self-expanding implant element typically made of a plurality of interconnected struts. The implant element defines an interior space having two open ends, a proximal end and a distal end. The inner and / or outer surfaces of the implant element can be covered to support at least one graft material.
The extension prosthesis 160 typically includes a support implant matrix or element that supports a graft material. One end of the extension prosthesis is typically adapted to occupy one or more portions of the second prosthesis 11 a, b. In preferred embodiments of the invention, the distal end of the second prosthesis 11 a, b is adapted to hold coupled a proximal portion 161 of the extension prosthesis 160. In preferred embodiments of the invention, the coupling between the second prosthesis and the prosthesis The extension is narrow fluid, specifically narrow blood. One skilled in the art will recognize that there are a variety of configurations and structures in one or both of the second prosthesis or the extension prosthesis, which can provide mechanical strength to the separation at the joint between the two prostheses. Such configurations and alternative structures are included within the present invention. To adapt the extension prosthesis to occupy the second prosthesis, the proximal end of the extension prosthesis may be widened or not widened. In an exemplary embodiment of the invention, the proximal end of the extension prosthesis 160 may be slightly enlarged closely, preferably to make it easier to maintain the coupling between the second prosthesis and the extension prosthesis. It is intended that the length of the enlarged portion of the extension prosthesis be approximately the length of overlap between the distal end of the second prosthesis and the proximal end of the extension prosthesis.
The extension prosthesis may also optionally include at least one linker structure at its distal portion 162 to occupy and secure the prosthesis in a portion of the artery downstream of the aneurysm. These and other features of the extension prosthesis will be described in more detail below. In accordance with the present invention, the communication between the second prosthesis or derivation and the extension prosthesis (s) may include one or more elements that in combination effect a narrow sealing of the fluid. As noted above, narrow sealing of fluid can be accomplished by adherently sealing an extension receptacle 240 (Figure 16a) around the interior of a distal portion of the second prosthesis or bypass. In an exemplary embodiment of the invention, the extension receptacle 240 completely occludes the fluid flow path through the bypass prosthesis. In this exemplary embodiment of the invention, the extension receptacle 240 may be pierced or opened in a centrally located portion in order to occupy or receive the extension prosthesis. In another exemplary embodiment of the invention, the extension receptacle 240 may include one or more openings configured to receive an extension prosthesis. In accordance with the present invention, the extension receptacle 240 may be formed of a gasket material, preferably a compressible gasket material. The gasket material may comprise any suitable material. The gasket material can be formed of any number of materials known to those of ordinary skill in the art, including open cell foam materials and closed cell foam materials. Exemplary materials include polyurethane, polyethylene, polytetrafluoroethylene, various other polymer materials that are woven or spun to provide a flexible structure such as Dacron®. Highly compressible foams are particularly preferred to maintain the low ripple profile for better delivery. The gasket material for the extension receptacle 240 can be bonded in any number of appropriate ways. As illustrated in Figure 3, the joint 30 for the first prosthesis can be linked to the expandable member 12 by any number of means including a plurality of conventional polyvinylidene fluoride sutures., polypropylene, Dacron®, or any other appropriate material and link to it. Other methods of bonding the joint 30 or an expandable member or implant member include adhesives, ultrasonic tissue, mechanical interference placement and staples, or a combination of these methods. Any of these methods may be used with the extension receptacle 240. As will be apparent to one skilled in the art, it may be desired for the system and / or one or more of the prostheses described above to perform a fluid flow path as long as possible, within the confines of an artery. As noted above, the size of the fluid flow path is in part defined by the size of the lumen of an implant element or prosthesis. It has been determined that the lowest functional diameter of a prosthesis or implant element should be greater than about 6 mm, preferably about 12 mm. As seen from Figures 18 and 19, an exemplary extension receptacle 240 may comprise an occlusive member 241 bonded to the distal portion of the second prosthesis or bypass 1 1 a, b. The occlusive member 241 may cover a predetermined portion of the interior of the bypass prosthesis. The extension receptacle 240 covers the interior of the bypass prosthesis such that the lumen 242 of the extension receptacle provides access between the proximal and distal ends of the bypass prosthesis. In an exemplary embodiment, the blocks covering about half of the lumen are taken from a cross section of the bypass prosthesis perpendicular to its longitudinal axis. The occlusive member 241 further includes an opening extension therebetween to receive a guidewire 202 to guide one or more prostheses to the target site. Subsequently, when a second guidewire 204 is inserted for a second prosthesis, the occlusive member 241 will prevent it from going through the same opening as the guidewire 202 is placed, and will force it to go through the other half of the guidewire. inside the extension receptacle 240. This helps ensure the placement side by side of the two prostheses. Another exemplary embodiment of the extension receptacle of the present invention is shown in Figure 19. In this exemplary embodiment, the extension receptacle is a gasket or the like configured to occupy or cover the distal end of the second prosthesis or bypass, the extension receptacle comprises an integral joint member and an occlusive member 233. The occlusive member 233 is much more like a cylinder that tapers around the top of the implant member and along its sides. The occlusive member 233 has a small opening or slot 250 for accommodating the initial guide wire that is deploying therein, and a large opening 242 for inserting the second guide wire after the prosthesis has been deployed.
Implant Element Any of the implant elements of the present invention can form a support or grid structure suitable for supporting a graft material. In preferred embodiments of the invention, the implant member defines a channel through which a fluid, such as blood, can flow. A typical implant element comprises an expandable grid or channel of interconnected struts. In preferred embodiments of the invention, the grid is machined from an integral tube of material. In accordance with the present invention, the implant element can be configured in different manners. For example, the implant element can be configured with struts or the like that form repeated geometric shapes. One skilled in the art will recognize that an implant element can be configured or adapted, to include certain features and / or to perform certain functions, and what alternative designs can be used to promote such a feature or function. In some exemplary embodiments of the invention, the struts of the implant element seal form a matrix that is diamond-shaped. In exemplary embodiments of the invention shown in Figure 2, the matrix or struts of the implant element 10 are shaped into a diamond, preferably having approximately eight diamonds. In this exemplary embodiment of the invention, the fully expanded diamond pattern of a first prosthesis has angles of forty-five to fifty-five degrees at its distal and proximal ends. In the exemplary embodiment of the invention shown in Figure 5, the matrix or struts of the implant element 40 can be configured in at least two rings 43, each ring 43 comprises a number of struts 44 having the diamond shape, which have approximately nine diamonds A second prosthesis, such as the second prosthesis 40, may further include a zigzag-shaped ring 50 for connecting the adjacent rings one to the other. The zigzag-shaped rings can be formed from a number of alternative struts 52, where each ring has fifty-four struts. The diamond pattern for the anchors, as well as for the other rings, provides the rings with radial and longitudinal rigidity. The longitudinal strength is provided for a better mechanical fixation of the implant element 40 to the graft material (described below). The radial resistance gives the proximal ring 45a better fixation and sealing to the joint material, and provides the distal ring 45b with better fixation and sealing to the arterial wall. In addition, the distal ring may be enlarged, and may be exposed after the graft material has been bonded to the implant member. In a preferred exemplary embodiment, the proximal and distal rings have a greater longitudinal and radial strength than the rings between them. This creates an implant element graft that has widened ends for anchoring, but a more flexible body for navigation through vascularity. The flared ends can be attached to change the dimensions of the struts for the final loops, or to vary the heat treatment of the final loops during manufacturing. The rings allow the implant element to mix more easily, and generally provide greater flexibility when the implant element is delivered through a tortuous vessel. When an uncoupled graft is bonded to an implant element, the strength of the diamond rings forms scaffolds in any graft fold in the blood flow lumen, while maintaining a narrow twisting radius. In accordance with some embodiments of the present invention, the proximal and / or distal ends of an implant member may include one or more anchors and / or one or more struts of the implant member configured in an anchor. One or more anchors, commonly referred to as recapture limbs, may also be configured to releasably occupy a delivery device, such as a catheter, or a portion thereof. The distal end of the implant element is preferably configured to occupy a complementary structure in a delivery device, such as a catheter or a portion thereof. For example, the distal end of the implant element may include one or more keys that occupy, preferably releasably occupy, a corresponding lock in the catheter. An exemplary configuration is shown in Figure 15. It is intended that the invention not be limited by the precise structures and used to occupy the implant element for the delivery device. In exemplary embodiments of the invention shown in Figures 1-3 and 15, the implant member may include one or more anchors 28, 46 configured to occupy a corresponding structure in the delivery device 130. In accordance with the present invention, The delivery apparatus may include a collar having one or more slots or the like adapted to releasably occupy one or more structures in an implant element or prosthesis of the present invention. For example, the delivery apparatus shown in Figure 7 includes eight slots 144 for configuring the delivery device to releasably occupy both the first prosthesis 10 in Figure 1 (having eight anchors 28 as illustrated in Figure 2) , and the delivery apparatus shown in Figure 15 which includes three slots 144 for configuring the delivery device to releasably occupy the second prosthesis 11a, b in Figure 15 (having three anchors 46). Such configuration of the anchoring / delivery device is particularly appropriate for partially deploying a prosthesis of the present invention, and for placing or relocating the prosthesis. Any of the implant elements of the present invention can be formed of any material suitable for in vivo operation as a support for graft material. An implant element of the present invention can be formed from a wide variety of materials, all of which are well known to those skilled in the art. In some exemplary embodiments of the invention, the implant element is formed of a metal or metal alloy. In preferred embodiments of the invention, the implant element is formed of super elastic nickel titanium alloys (Nitinol). Descriptions of medical devices using such alloys can be found in the U.S.A. 4,665,906 and European patent application EP 0928606, both of which are hereby incorporated by reference. An implant element in accordance with the present invention is preferably cut with a tubular piece of nitinol laser and subsequently treated to exhibit memory properties formed at body temperature. In preferred embodiments of the invention, the implant element material is expandable or collapsible, that is, it can be moved from a first closed position to a second open position, or vice versa.
Graft material An internal or external surface of an implant element of the present invention can be covered by, or withstand, a graft material. The graft material 60 (Figures 4, 6, 8, 10, 11, 13, 14 and 15) can be made from any number of materials known to those skilled in the art, including woven polyester, Dacron®, Teflon®, polyurethane , porous polyurethane, silicone, polyethylene terephthalate, expanded polytetrafluoroethylene (pPTFE) and mixtures of various materials. In some embodiments of the invention, it may be desired to incorporate a biodegradable or degradable material, such as albumin, collagen, or any type of collagen. A graft material that is biodegradable will erode or dissolve over time; it is considered that an erodible graft material can be replaced by one or more biofusion constituents. The graft material can be configured differently, preferably to realize predetermined mechanical properties. For example, the graft material can incorporate simple or multiple patterns of fabric and / or folding, or it can be folded or not folded. For example, the graft may be formed into a folded fabric, a satin fabric, including continuous longitudinal pleats, interrupted pleats, annular pleats, or ellipticals, radially oriented pleats, or combinations thereof. Alternatively, the graft material can be woven or braided. In exemplary embodiments of the invention in which the graft material is folded, the pleats may be continuous or discontinuous. Also the folds may be oriented longitudinally, circumferentially, or combinations thereof. As shown in Figure 6, the graft material 60 may include a plurality of longitudinal folds 61 extended along its surface, generally parallel to the longitudinal axis of the prosthesis. As shown in Figure 8, the folds allow the prosthesis to collapse around its center, such as when it is delivered to a patient. As illustrated, the folds will be together as a series of radially oriented regular folds that pack together efficiently. This provides a relatively low profile of the delivery system, and is provided to control and consistently develop the same. It is considered that this configuration minimizes wrinkles and other geometric irregularities. During the subsequent expansion, the prosthesis assumes its natural cylindrical shape, and the folds or folds open evenly and symmetrically. Furthermore, the folds 61 facilitate auxiliary manufacture of the implant element graft, in that they indicate the direction parallel to the longitudinal axis, allowing the implant element to be grafted in a way along these lines, and therefore inhibit accidental grafting of the graft in relation to the implant element after bonding. The force required to press the implant-graft element out of the delivery system can also be reduced, so that only the folded edges of the graft make frictional contact with the internal surface of the delivery system. An additional advantage of the folds is that the blood tends to coagulate generally uniformly in the crease channels, discouraging the formation of asymmetric or large thrombi on the surface of the graft, thereby reducing the risk of embolism. As shown in Figure 6, the graft material may also include one or more, and preferably a plurality, of radially oriented bend interruptions 70. The fold interruptions are typically substantially circular and oriented perpendicular to the longitudinal axis. The fold interruptions 70 allow the graft and the prosthesis to better bond to the selective points. This design is provided so that the graft material has good compatibility and better resistance to kinking. The graft material as described above, preferably it is highly compressible, which also promotes a low coupling profile for better supply characteristics. In accordance with the present invention, the graft material can be impenetrable or substantially impenetrable to blood flow, or it can be porous. A graft material is impenetrable to prevent blood from passing through the graft material in contact with the blood or after the graft material has been saturated with blood. The choice of flow characteristics of the graft material is well known to those skilled in the art, and is in part to the intended function of the prosthesis or portion of the prosthesis. For example, it may be desired for the graft material that forms the cover of the first prosthesis that is impenetrable or substantially impenetrable to blood flow. Alternatively, they may be desired for a graft material that is porous or partially porous to promote biofusion. Furthermore, it is preferable that the joint member be substantially impenetrable to blood flow, at least when it is in a partially compressed state. When used throughout the present invention, materials that are substantially impenetrable to blood flow include materials that become substantially impenetrable to blood flow after they are saturated with blood. A graft material can be linked to the implant member or other graft material by a number of structures or methods known to those skilled in the art, including adhesives, such as polyurethane rubber.; a plurality of conventional sutures of polyvinylidene fluoride, polypropylene, Dacron®, or any other suitable material; ultrasonic tissue; placement of mechanical interference; and staples. As stated above, an implant member preferably has a graft member bonded ther The graft member covers at least a portion of the interior or exterior of the implant member, and more preferably covers substantially all of the exterior of the implant element. In some exemplary embodiments of the invention, prosthesis 11 a, b includes graft material 60 that covers only a portion of distatal end 42 of matrix 40 (Figure 4). In an alternative design, the graft material may not be used at both ends of the implant member. For example, in any of the end portions, prostheses, extension folds, implant element joints or other cover implant element, both ends thereof may be left uncovered. The body has the ability to cover the exposed portions of the implant element with endothelial cells and thus expose portions that are endothelized or incorporated into the vessel walls. This can be an important factor in the long-term stability of the system. Essentially, for long periods of time, the aneurysmal sac can and should contract if it is totally excluded from the bloodstream. This contraction changes the morphology of the aortic region that has been treated with the bypass prosthesis. If all the ends of the system are firmly anchored in the current vessel, as in the case when the ends are covered with endothelial cells, the system will be able to better understand these morphological changes. In accordance with the present invention, it can be highly desirable to provide a graft material that limits or substantially eliminates the amount of blood passing between the graft and the arterial wall, to provide a graft or delivery prosthesis to the catheter extending through of a large portion of the artery, to improve the anchoring mechanism between 2 prostheses, to improve the anchoring mechanism between the prosthesis and the arterial wall or an interluminal cavity within an artery, and to improve dynamic fluid and performance characteristics of the implanted prosthesis.
Marker As noted above, an implant and / or prosthesis element of the present invention may include one or more markers. One skilled in the art will recognize that one or more markers can be placed on the implant element, the graft material or on the prosthesis. In preferred embodiments of the invention, the markers are used to identify the position of the implant element or prosthesis in relation to the body part and / or in relation to another implant element or prosthesis, and / or to identify the position of a part of the prosthesis in relation to another part. In more preferred embodiments of the invention, the markers are used to identify an in vivo position. As shown in Figures 2 and 3, an implant element, such as the implant element 12, preferably includes one or more radiation-opaque markers 15. Exemplary materials for forming markers include, but are not limited to tantalum, Platinum, iridium, and gold. As shown, the markers 15 are metal implant element opaque to radiation, entangled around the struts of the implant element. The markers 15 are preferably made of a diameter of 0.0075 inches (0.1905 mm) of tantalum (Ta) of wire entangled tightly around the struts. The number, location and size of the markers may vary, and the markers may be used alone or in combination to identify the portion of a particular portion of the prosthesis. For example, a nearby marker adjacent the opening 32 may be about 5 mm long and the marker near the hole 33 may be about 2 mm long. Also two distal markers can be separated one hundred and eighty degrees, and a nearby marker can be placed equidistant to each of the distal markers. In this exemplary configuration, the proximal marker then assists in proper rotation of the device position.
Connectors Some exemplary embodiments of the prosthesis in accordance with the present invention may include one or more connectors. In some exemplary embodiments of the invention, the connectors are used to occupy or connect one prosthesis or component to another. In some exemplary embodiments of the invention, the connectors may be used to link the joint material or the graft material to the implant member or grid. As noted above, one skilled in the art will recognize that a variety of materials and methodologies can be used to connect one prosthesis to another, or to link the graft material to the implant member. Exemplary connectors include, but are not limited to, sutures, staples, rivets, or the like. In preferred embodiments of the invention, the connector is a suture or staple, even more preferably, it has a seam or a knotted end. In addition, a connector can be formed of a radiation-opaque material or a fluorescent material, each of which allows the connector to be used as a marker. In accordance with the present invention, it may be desirable to incorporate a connector adapted for use with a grid-like implant element into a prosthesis. A first connector 54, an exemplary embodiment of which is shown in Figures 5 and 9-11, can be configured to be used in a final portion of an implant element, preferably in the end portion of a strut 44. A second connector 56 , an exemplary embodiment of which is shown in Figures 5 and 12-14, can be configured to be used in an internal portion of an implant element, preferably at the junction between two struts 44. Figure 9 shows a first connector or connector of proximal bond 54 of an implant element, such as implant element 40 (Figure 4). A ring may include a tongue 82 having a first opening 84 and a second opening 86, and preferably includes a notch 85 or the like at the opposite end of the strut. The tongue 82 can be a separate element configured to occupy an implant element or, as illustrated, can be formed from the joining of two struts 44a and 44b respectively. In the exemplary embodiment of the invention shown in Figures 9-1 1, the tongue 82 is configured to receive a strut 90 having a first end 94 and a second end 96. The first opening 84 is preferably configured to receive the portion of point of both the first end 94 and the second end 96 of the staple 90. The second opening 86 is preferably configured to allow a second end 96 to pass between them. In the exemplary embodiments of the invention including a notch 85, a portion of the first end 94 is opposite to the engagement of the tip or hooks in the notch 85. In use, the second end 96 passes through the graft material 60. , through the second opening 86 of the tongue 82 and a tip portion of the second end is placed in the first opening 84. The first end 94 of the clip 90 can be placed in the connector 54 when occupying the groove 85. A tip portion of the first limb is placed in the first opening 84. In an exemplary embodiment of the invention, the tip portion of the first and second limbs occupies, and preferably penetrates, the graft 60. In another exemplary embodiment of the invention, the tip portion of the first and second limbs occupies, but does not penetrate, the graft 60. According to preferred embodiments of the invention, a prosthesis can be kept occupied in another prosthesis using a connector that has a spherical knot or end. Exemplary connectors of this aspect of the invention, include, but are not limited to, a rivet, staple, suture, or combinations thereof. An exemplary connector assembled for this exemplary embodiment of the invention is shown in Figures 17a and 17b.
Figure 17a is an exemplary connector of the implant element 40 of the second prosthesis 11a, b as illustrated in Figures 4 and 5, and an exemplary proximal connector on the implant member 40 of the third prosthesis or extension 160 (illustrated in Figure 16). The connector is preferably formed from a tongue 82 or the like at the junction of the two struts, 44a, and 44b. The tongue 82 includes an opening 87 near the end 88 of the tongue opposite the struts, the opening being configured to receive the rivet, suture or staple 90 (Figure 10), or the like. Figure 17b shows the maintained coupling of the second prosthesis 1 1a, b and the third prosthesis 160. As illustrated, the second prosthesis 1 1 a, b includes a distal end 88a having a graft material 60a that covers an interior surface of the implant element 40a. The third prosthesis 160 includes a proximal end 88 having a graft material 60b that covers an inner surface of the implant member 40b. After the ends 88a and 88b are aligned, a portion of the suture / staple 90 or the like is passed through the opening 87. In the illustrated embodiment, the suture / staple 90 includes a crown 92 that bridges an interior surface. of the prosthesis 1 1a, b and the prosthesis 160. The suture / staple 90 includes a first end 94 that passes through the opening 87a and a second end 96 that passes through the opening 87b. Once the suture and the prosthesis are aligned and in place, the tip of the first limb 94 and the second limb 96, distal of the crown 92, and placed on the inner surface of the struts 40a and 40b, can be configured in a knot or spherical element 170a and 1 0b. It will be apparent to one skilled in the art that the knot should be of a large diameter greater than the diameter of the opening. In a preferred embodiment of the invention, the knots 170a and 170b can be formed by melting the respective tips. The present invention also includes an alternative exemplary embodiment for connecting the second prosthesis to the third prosthesis. In this alternative exemplary embodiment (not shown), the openings 87a and 87b are aligned and a rivet having two tips is passed through the aligned openings. Each tip can then be configured into a knot or the like, as described above. In this embodiment of the invention, the second prosthesis remains occupied in the third prosthesis using one or more rivets that are formed from a bar once the knots have been formed. The structures and functions of the second connector 56, illustrated in Figures 12-14, are similar or are the same as those described above for the first connector. However, in a second connector configuration, the tongue also includes a third opening 1 12, preferably configured to allow the first end 124 of the staple 120 to pass between them. In use, first end 124 and second end 126 pass through graft material 160, first end 124 passes through third opening 12 and second end 126 passes through second opening 16, and a portion of the tongue of each of the first and second limbs are bent into the first opening 114. In an exemplary embodiment of the invention, the tongue portion of the first and second limbs occupies, and preferably penetrates, the material of the first and second ends. graft 60. In another exemplary embodiment of the invention, the tongue portion of the first and second limbs occupies, but does not penetrate, the graft 60. The second connector 56 is used with struts 44c, d, e, f. The number of connectors and staples is typically dictated by the size and structure of a particular implant element; it is intended that the invention is not limited by this. The illustrative modalities show six first connectors and three second connectors. The design of the anterior staple opening or assembly connector, has many advantages for linking the joint material or the graft material to the implant element. Because the ends of the staple are folded around and inserted into a package or the like, any risk of puncture of the inflation balloon is minimized. In addition, the structural integrity of the prosthesis is increased because the staples are more securely attached to the graft material of the implant member, as compared to prior art designs that use sutures or adhesives to attach the graft to the implant member. implant. Staples 90 and 120 can be made from any number of materials known in the art, including tantalum alloys, platinum alloys, or stainless steel, such as a grade of 316 stainless steel type. Staples can be taken in other configurations and shapes , and can be coated for lubrication purposes, wear resistance and corrosion prevention. Essentially, the coating can be used to increase the durability. The staples can be formed from a radiation opaque material to identify the location of the staple, and to act as a marker to identify the location of a portion of the prosthesis. Different number of staples opaque to radiation at the distal end of an implant element compared to the proximal end, is further assisted to identify the position of the prosthesis.
Methods A method according to the present invention includes the delivery and positioning of a first prosthesis in a fluid conduit, such as an aorta. In preferred embodiments of the invention, the first prosthesis is an implant element seal, or even more preferably an implant element seal that automatically expands against the walls of the artery. When the implant element joint expands the proximal longitudinal limbs allow the implant element to join the diamond rings to expand, whereby the implant element is anchored in place. The method also includes supplying and positioning at least one second prosthesis. In preferred embodiments of the invention, the second prosthesis is a bypass conduit for extending through an aneurysm. The second prosthesis is typically placed within the first prosthesis, preferably in and through a hole in the first covered prosthesis. In more preferred embodiments of the invention, the hole is slightly smaller in diameter than the expanded diameter of the second prosthesis, thus sealingly sealing the second prosthesis in the first prosthesis. The sealing configuration of the second prosthesis within the first prosthesis forms a fluid pathway through the assembly or system, whereby the aneurysm is deflected. Figures 1, 7 and 15 generally show that the system of the present invention can be developed in vivo. One skilled in the art will readily recognize that a typical delivery device, such as a catheter, includes a guidewire or the like which passes through an opening in the cover of the first prosthesis, and a collar or the like that it occupies releasably. at least one anchor in the prosthesis. Once the anchors are released from the collar, the first prosthesis can expand, preferably automatically. The portion of the delivery device containing the collar can then be removed from the artery typically by bringing the guidewire into place, that is, by still placing an opening in the first cover prosthesis. The guide wire can then be used to guide a second prosthesis into position within the first prosthesis. In some exemplary embodiments of the present invention, the collar of the delivery device, which occupies the prosthesis, can be placed in a similar case until the prosthesis is delivered. In preferred embodiments of the invention, a portion of the prosthesis can be deployed and / or partially placed. Once it is determined that the prosthesis is in its proper position, the collar can be pressed out of the packing, whereby the anchors of the collar are released. If the prosthesis is a self-expanding prosthesis, the release of the eyelashes will allow the prosthesis to unfold automatically. If the prosthesis is not self-expanding, a deflation balloon can be delivered to the interior of the prosthesis using the guidewire. When the balloon is inflated, it will expand the prosthesis in its fully deployed position, that is, completely radially expanded. In preferred embodiments of the invention, the system is used to derive an abdominal aortic aneurysm (AAA). A method for treating or deriving an AAA includes supplying, preferably percutaneously, a first prosthesis or precursor implant element, or one of its components (for example, the joint member can be supplied separately if desired). The components of the system are typically delivered through one of the femoral arteries and deployed within the infrarenal neck between an abdominal aortic aneurysm and the patient's renal arteries. Once the first prosthesis is properly placed or repositioned, the limbs and anchors are completely released from the delivery device. The delivery device for the precursor implant element can then be removed without removing the guidewire, and another guidewire can be inserted through another femoral artery and into the first prosthesis. If the second guidewire is on the wrong inner side of the first prosthesis, it will contact the occlusive member and prevent easy advancement.
The physician can then properly reposition the guide wire through the orifice 32. Subsequently each delivery apparatus, each containing a second packaged prosthesis, is inserted into the iliac arteries 1 and 2 by sliding them over the guide wires; each of the second 2 prostheses is then placed in the first prosthesis. Subsequently, the second prosthesis can be deployed either separately or simultaneously. After properly delivering, the first prosthesis 10 and the first prosthesis 1 1a and 1 1 b should appear as shown in Figure 1. The first prosthesis 10 together with the bonded joint material 30 is firmly secured within the infrarenal neck 101. External force of the second prosthesis 11a, b in the precursor implant element 10, helps to secure the device within the body. The distal ends of the second prosthesis are firmly linked to the iliac arteries 1 and 2. Subsequently blood will flow from the abdominal aorta 302 above the aneurysm 100, through an exemplary system of the present invention comprising a first prosthesis and 2 second ones. prostheses 1 1a and 1 1 b, and in the iliac arteries 1 and 2, so it passes avoiding the aneurysm 100. It is important to note that although self-expanding implant elements are used balloons can be used to take them in the position if necessary.
Although what is considered to be most practical in the preferred embodiments is shown and described, it will be apparent that departures from the specific designs and methods described and shown will suggest themselves to those skilled in the art, and that they can be used. without leaving the spirit and scope of the invention. The present invention is not restricted to the particular constructions described and illustrated, but should be constructed in a manner consistent with all modifications that may fall within the scope of the appended claims.

Claims (81)

  1. NOVELTY OF THE INVENTION CLAIMS 1. A system for deriving an aneurysm, characterized in that it comprises at least one bypass prosthesis and at least one extension prosthesis, the bypass prosthesis comprises an extension socket in a distal portion thereof, the extension prosthesis has an adapted proximal portion to occupy the extension receptacle. 2. The system according to claim 1, further characterized in that it comprises an extension receptacle having a first portion adapted to receive the first extension prosthesis and a second portion adapted to receive the second extension prosthesis; the system further comprises a first extension prosthesis having a proximal portion configured to occupy the first portion of the extension receptacle, and a second extension prosthesis having a proximal portion configured to occupy the second portion of the extension receptacle. 3. The system according to claim 1, further characterized in that the bypass prosthesis comprises an implant element and a graft material communicated with the implant element. 4. - The system according to claim 3, further characterized in that the implant element and the graft material define a fluid flow path through the prosthesis. 5. - The system according to claim 1, further characterized in that the extension prosthesis comprises an implant element and a graft material communicated with the implant element. 6. The system according to claim 5, further characterized in that the implant element and the graft material define a fluid flow path through the prosthesis. 7. - The system according to claim 1, further characterized in that the distal portion of the bypass prosthesis is adapted to occupy a proximal portion of the extension prosthesis. 8. - The system according to claim 7, characterized in that the distal portion of the bypass prosthesis comprises at least one anchor. 9. - The system according to claim 8, further characterized in that the anchor is configured to occupy a complementary structure in the proximal portion of the extension prosthesis. 10. The system according to claim 9, further characterized in that the anchor is further adapted to occupy the complementary structure in a delivery device. The system according to claim 1, further characterized in that the extension receptacle comprises at least one opening configured to receive a proximal portion of the extension prosthesis. 12. The system according to claim 11, further characterized by comprising two openings, each opening configured to receive a proximal portion of an extension prosthesis. 13. - The system according to claim 11, further characterized in that the extension receptacle further comprises a gasket for sealingly receiving a proximal portion of the extension prosthesis. 14. - The system according to claim 12, further characterized in that the extension receptacle further comprises a gasket for sealingly receiving the proximal portion of the extension prosthesis. 15. - The system according to claim 1, further characterized in that the extension receptacle is formed to seal a distal end of the bypass prosthesis. 16. - The system according to claim 11, further characterized in that the extension receptacle is formed to seal the distal end of the bypass prosthesis. 17. - The system according to claim 13, further characterized in that the seal is formed to seal the distal end of the bypass prosthesis. 18. - The system according to claim 5, further characterized in that the implant element is a self-expanding implant element. 19. - The system according to claim 18, wherein the implant element is formed of at least one metal. 20. - The system according to claim 18, further characterized in that the implant element is formed of a nickel titanium alloy. 21. - The system according to claim 19, further characterized in that the implant element is formed of nitinol. 22. - The system according to claim 5, further characterized in that the implant element comprises a matrix of interconnected struts. 23. - The system according to claim 18, further characterized in that the implant element comprises a matrix of interconnected struts. 24. The system according to claim 23, further characterized in that the matrix comprises at least one geometric shape. 25. - The system according to claim 23, further characterized in that the interconnected struts form at least one geometric shape. 26. - The system according to claim 24, further characterized in that the matrix comprises a plurality of geometric shapes. 27. - The system according to claim 26, further characterized in that the plurality of geometric shapes is placed in an intermediate portion of the implant element between the proximal end and the distal end of the implant element. 28. - The system according to claim 24, further characterized in that the geometric shape is a diamond. 29. - The system according to claim 24, further characterized in that the matrix is formed of at least one ring. 30. The system according to claim 29, further characterized in that the matrix is formed of a distal ring, a proximal ring, and at least one intermediate ring interposed between the distal ring and the proximal ring. 31. The system according to claim 30, further characterized in that the distal ring is more rigid than the intermediate ring. 32. - The system according to claim 30, further characterized in that the proximal ring is more rigid than the intermediate ring. 33. - The system according to claim 30, further characterized in that the distal ring and the proximal ring are stiffer than the intermediate ring. 34. - The system according to claim 30, further characterized in that the intermediate ring is more flexible than the proximal ring. 35.- The system according to claim 34, further characterized in that the intermediate ring is more flexible than the distal ring. 36. The system according to claim 5, further characterized in that the graft material occupies an internal surface of the implant element, an external surface of the implant element, or combinations thereof. 37. - The system according to claim 36, further characterized in that the graft material is connected to the implant element. 38.- The system according to claim 5, further characterized in that it comprises at least one connector for linking the graft material to the implant element. 39. - The system according to claim 38, further characterized in that the connector is a staple or suture. 40. - The system according to claim 39, further characterized in that the connector comprises at least one end configured in a node. 41. - The system according to claim 40, further characterized in that the connector comprises two ends, each end being configured in a node. 42. The system according to claim 5, further characterized in that the graft material is formed from polyester, a fluoroethylene, a polyurethane, a polyethylene terephthalate, a silicone, or combinations thereof. 43. - The system according to claim 42, further characterized in that the graft material is formed from a polyethylene terephthalate, a polytetrafluoroethylene, or combinations thereof. 44. - The system according to claim 5, further characterized in that the graft material is folded. 45. - The system according to claim 43, further characterized in that the graft material is folded. 46.- The system according to claim 23, further characterized in that the matrix comprises at least one ring. 47.- The system according to claim 29, further characterized in that the matrix comprises at least one ring. 48. - The system according to claim 47, further characterized in that the matrix comprises at least one ring interposed between two rings. 49. - The system according to claim 46, further characterized in that the ring is formed from the ends of a plurality of interconnected struts. 50. - The system according to claim 1, further characterized in that the proximal portion of the extension prosthesis further comprises a joint for sealingly occupying the bypass prosthesis. 51. - The system according to claim 1, further characterized in that the proximal portion of the extension prosthesis further comprises a joint for sealingly occupying the extension receptacle. 52. The system according to claim 1, further characterized in that the extension prosthesis further comprises a distal portion configured to occupy an artery. 53. The system according to claim 52, further characterized in that the distal portion of the bypass prosthesis comprises at least one anchor. 54. - The system according to claim 53, further characterized in that the anchor is further adapted to occupy a complementary structure in the delivery device. 55. - The system according to claim 1, further characterized in that it comprises a first prosthesis adapted to occupy a proximal portion of the bypass prosthesis. 56. - The system according to claim 55, further characterized in that the first prosthesis comprises an implant element and a joint material communicated with the implant element. 57. - The system according to claim 55, further characterized in that it comprises one or more connectors to keep the first prosthesis occupied with the bypass prosthesis, at least one connector comprises a connector having two ends, each of the two ends It is configured in a knot. 58. - The system according to claim 55, further characterized in that the first prosthesis is adapted to occupy a portion of an artery upstream of an aneurysm. 59. The system according to claim 58 further characterized in that the first prosthesis comprises at least one distally extended flange. 60. - The system according to claim 59, further characterized in that the flange comprises an anchor at a distal end. 61 - The system according to claim 60, further characterized in that the anchor is further adapted to occupy a complementary structure in a delivery device. 62. - The system according to claim 55, further characterized in that the proximal portion of the first prosthesis is adapted to occupy a proximal portion of the bypass prosthesis. 63. - The system according to claim 62, further characterized in that the proximal portion of the first prosthesis is adapted to occupy the proximal portion of two bypass prostheses. 64. - The system according to claim 1, further characterized in that it comprises at least one marker placed in the bypass prosthesis, the extension prosthesis, or combinations thereof. 65. - The system according to claim 64, further characterized in that at least one marker is placed in a proximal portion of the bypass prosthesis. 66. - The system according to claim 64, further characterized in that at least one marker is placed in a distal portion of the bypass prosthesis. 67. - The system according to claim 66, further characterized in that at least one marker is placed in a distal portion of the bypass prosthesis. 68.- The system according to claim 64, further characterized in that at least one marker is placed in a proximal portion of the extension prosthesis. 69. - The system according to claim 64, further characterized in that at least one marker is placed in a distal portion of the extension prosthesis. 70. - The system according to claim 69, further characterized in that at least one marker is placed in a distal portion of the extension prosthesis. 71 - The system according to claim 55, further characterized in that at least one marker is placed in a proximal portion of the first prosthesis. 72. The system according to claim 55, further characterized in that at least one marker is placed in a distal portion of the first prosthesis. 73.- The system according to claim 1, further characterized in that the aneurysm is located in an artery. 74.- The system according to claim 73, further characterized in that the artery is an abdominal aorta. 75.- The system according to claim 73, further characterized in that the bypass prosthesis is adapted to occupy an abdominal aorta. The system according to claim 73, further characterized in that the proximal portion of the extension prosthesis is adapted to occupy the proximal portion of the distal end of the bypass prosthesis. 77. - The system according to claim 73, further characterized in that the distal portion of the extension prosthesis is adapted to occupy an iliac artery. 78. The system according to claim 76, further characterized in that the distal portion of the extension prosthesis is adapted to occupy an iliac artery. 79. A system for stabilizing a fluid flow path of a portion of an artery in a branched portion of a portion below an arterial channel, characterized in that it comprises a bypass prosthesis communicated with a segment upstream of an artery, the bypass prosthesis has a distal end; a first extension prosthesis configured to occupy the distal end portion of the bypass prosthesis, the first extension extending into a first branch portion of a downstream artery; and a second extension prosthesis configured to occupy a portion of the distal end of the bypass prosthesis, the second extension extended into a second branch portion of a downstream artery. 80. - A method for deriving a portion of an artery between a simple proximal portion and a bifurcated distal portion, characterized in that it comprises providing a bypass prosthesis, and sealingly occupying at least one extension prosthesis in a distal portion of the prosthesis Bypass, the extended extension prosthesis in the bifurcated portion of the artery. 81. - A delivery method for placing the prosthesis in an iliac artery, characterized in that it comprises passing a guidewire through a bypass prosthesis proximally until distally and in the internal iliac artery; supplying an extension prosthesis on the guide wire distally until next, and in the internal iliac artery; and deploying the extension prosthesis with a trailed end of the extension prosthesis while keeping the distal portion of the bypass prosthesis occupied.
MXPA03000283A 2002-01-08 2003-01-08 Bilateral extension prosthesis and method of delivery. MXPA03000283A (en)

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EP1325714A2 (en) 2003-07-09
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CA2415976A1 (en) 2003-07-08
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